Wearable Gait Interventions for Augmenting Paretic Propulsion: Towards Personalized Post-Stroke Gait Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Unassisted Overground Comfortable Walking Speed (Exosuit Day)
研究概览
简要总结
The objective of this study is to understand whether certain post-stroke patient subsets, identified from clinical, biomechanical, and neuromuscular characteristics, preferentially respond to different walking rehabilitation interventions that augment paretic limb propulsion (e.g., soft robotic exosuits or electrical stimulation neuroprostheses). The results of this work could improve post-stroke gait recovery outcomes by informing clinical decision-making to better match patients with rehabilitation devices tailored to their specific gait characteristics.
详细描述
Stroke is a leading cause of long-term disability that results in slow, asymmetrical, and inefficient walking. Personalized treatments matching patients to the treatments with which they are most likely to respond are not typical but are necessary to maximize recovery.
Post-stroke hemiparesis is commonly associated with reduced paretic limb propulsion that leads to slower, less efficient walking patterns. Our team has developed and tested two rehabilitation technologies targeting paretic propulsion: i) a soft robotic exosuit that uses cables to mechanically assist ankle dorsiflexion and plantarflexion during walking; ii) a neuroprosthesis that uses functional electrical stimulation (FES) to activate the dorsiflexor and plantarflexor muscles during walking. Both technologies aim to safely improve walking speed and paretic propulsion. The objective of this study is to evaluate if certain post-stroke patient subsets, identified from baseline clinical, biomechanical, and neuromuscular characteristics, preferentially respond to propulsion rehabilitation using soft robotic exosuits or electrical stimulation neuroprostheses.
Twenty participants with chronic (>6 months) stroke will complete one baseline gait evaluation in the laboratory and two gait training sessions: i) an exosuit day and ii) a neuroprosthesis day. Each visit will include walking with/without the respective technology.
The primary aim of this study is to identify predictors of a therapeutic response (i.e., improvement in walking speed) to determine whether certain patient subsets preferentially respond to the exosuit or the neuroprosthesis. We will evaluate baseline clinical, biomechanical, and neuromuscular abilities as potential predictors of a response. We hypothesize that a subset of individuals will respond preferentially to each intervention and that baseline measures of gait function will predict responders to each intervention.
A secondary aim of this study is to determine the rehabilitation mechanism underlying improved walking speed after walking with the propulsion exosuit and the neuroprosthesis. Improvements in walking speed can be achieved through recovery (e.g., increased propulsion symmetry) or compensation (e.g., increased nonparetic propulsion). We will independently evaluate the underlying biomechanical changes contributing to improvements in speed and metabolic cost. We hypothesize that both the exosuit and neuroprosthesis will promote improved speed via recovery of paretic propulsion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a stroke event occurring at least 6 months ago
- •Observable gait deficits
- •Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- •Passive ankle dorsiflexion range of motion to neutral with the knee extended
- •Ability to follow a 3-step command
- •Resting heart rate between 40-100 bpm
- •Resting blood pressure between 90/60 and 170/90 mmHg
- •NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
- •HIPAA authorization to allow communication with healthcare provider
- •Medical clearance by a physician
排除标准
- •Severe aphasia or inability to communicate with investigators
- •Neglect or hemianopia
- •Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- •Serious comorbidities that may interfere with ability to participate in the research (e.g., musculoskeletal, cardiovascular, pulmonary)
- •Pacemakers or similar electrical implants that could be affected by the FES
- •Pressure ulcers or skin wounds located near human-device interface sites
- •More than 2 unexplained falls in the previous month
- •Actively receiving physical therapy for walking
研究组 & 干预措施
Exosuit Training
A single 30-minute training of goal-directed overground walking practice at a moderately fast speed with a soft robotic exosuit powered on and off. Shorter overground and treadmill evaluations without the exosuit will be completed immediately before and after the training.
干预措施: Soft robotic exosuit (Device)
Neuroprosthesis Training
A single 30-minute training of goal-directed overground walking practice at a moderately fast speed with the propulsion neuroprosthesis powered on and off. Shorter overground and treadmill evaluations without neurostimulation will be completed immediately before and after the training.
干预措施: Propulsion neuroprosthesis (Device)
结局指标
主要结局
Unassisted Overground Comfortable Walking Speed (Exosuit Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test on the training day with the soft robotic exosuit.
Unassisted Overground Fast Walking Speed (Exosuit Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected fast pace using the 10-Meter Walk Test on the training day with the soft robotic exosuit.
Unassisted Paretic Propulsion on Treadmill (Exosuit Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Paretic propulsion during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Energy Efficiency on Treadmill (Exosuit Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Energy efficiency during walking on the treadmill without assistance on the training day with the soft robotic exosuit at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Energy efficiency is measured using indirect calorimetry on a breath-by-breath basis and is calculated as the negative net energy cost of walking with respect to standing rest.
Unassisted Overground Comfortable Walking Speed (Neuroprosthesis Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis.
Unassisted Overground Fast Walking Speed (Neuroprosthesis Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Walking speed without assistance measured at a self-selected fast pace using the 10-Meter Walk Test on the training day with the propulsion neuroprosthesis.
Unassisted Paretic Propulsion on Treadmill (Neuroprosthesis Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Paretic propulsion during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Energy Efficiency on Treadmill (Neuroprosthesis Day)
时间窗: Periprocedural (Before); Periprocedural (After)
Energy efficiency during walking on the treadmill without assistance on the training day with the propulsion neuroprosthesis at a speed determined by the average walking speed during the 6-Minute Walk Test on the Baseline Evaluation. Energy efficiency is measured using indirect calorimetry on a breath-by-breath basis and is calculated as the negative net energy cost of walking with respect to standing rest.
次要结局
- Unassisted Overground Paretic Propulsion at Comfortable Speed (Exosuit Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Exosuit Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Propulsion at Fast Speed (Exosuit Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Exosuit Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Paretic Trailing Limb Angle on Treadmill (Exosuit Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Propulsion at Comfortable Speed (Neuroprosthesis Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Trailing Limb Angle at Comfortable Speed (Neuroprosthesis Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Propulsion at Fast Speed (Neuroprosthesis Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Overground Paretic Trailing Limb Angle at Fast Speed (Neuroprosthesis Day)(Periprocedural (Before); Periprocedural (After))
- Unassisted Paretic Trailing Limb Angle on Treadmill (Neuroprosthesis Day)(Periprocedural (Before); Periprocedural (After))
研究者
Lou Awad, PT, DPT, PhD
Assistant Professor
Boston University Charles River Campus